FDA Adverse Event Malfunction Summary report: N

VITALITY

MDR report key: 3041134 · Received April 8, 2013

Report

Report Number: 2124215-2013-00679
Event Type: Malfunction
Date Received: April 8, 2013
Date of Event: January 10, 2013
Report Date: January 11, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, ERI WAS REACHED EARLIER THAN EXPECTED DUE TO A HIGHER-THAN-TYPICAL BUILDUP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

Additional Manufacturer Narrative · 1

THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
143314	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T125

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR			T125\| 0185\| E143\| 4470